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CompletedNCT03260361ProHKM-SDRCUpdated Aug 23, 2023

Hypnosis and MEOPA in Regional Painful Syndrome Complex

An interventional study of Hypnosis, kinesitherapy, MEOPA and Usual practice in Algodystrophy of Hand, sponsored by University Hospital, Toulouse. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-23.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Relation between hypnosis and MEOPA on algodystrophy.

02

Conditions studied

  • Algodystrophy of Hand
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Regional Painful Syndrome Complex

Exclusion criteria

Exclusion Criteria:

  • deaf people
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Hypnosis Kinesitherapy and MEOPA

    combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)

    Other: Hypnosis, kinesitherapy, MEOPA

  • Other
    usual practice

    physiopathology and treatments

    Other: Usual practice

Interventions

  • OtherHypnosis, kinesitherapy, MEOPA

    classical intervention

    Also known as: Hypnosis Kinesitherapy and MEOPA (HKM)

  • OtherUsual practice

    Usual practice with treatments and physio

05

What researchers measure

Primary outcomes

  1. Pain intensity measure using visual analogical ladder (EVA)

    pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson

    Time frame: 3 weeks

Secondary outcomes

  1. QDSA ( Saint Antoine Pain Questions)

    description of the type of pain

    Time frame: 3 weeks

  2. SF36 (Short Form (36) Health Survey)

    quality of life appreciation

    Time frame: 3 weeks

  3. HADs

    Hospital Anxiety and Depression Scale

    Time frame: 3 weeks

06

Study locations

2 sites
  • Croix du Sud
    Quint Fonsegrives, 31130, France
  • University Hospital of Toulouse
    Toulouse, 31059, France
07

References and documents

Publications

  • Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32. doi: 10.1097/00002508-199909000-00010. PubMed 10524476 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03260361
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Sep 6, 2017
Primary completion
Nov 7, 2022
Completion
Dec 7, 2022
Last update
Aug 23, 2023

Study contacts

Martine QUINTARD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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